Geta Bichutsky Email & Phone Number

An accomplished, professional executive with over 20 years of progressive technical and managerial experience in the pharmaceutical industry in the areas of Quality Control, Quality Assurance, Compliance, Regulatory, Operational Excellence. Successfully leverage scientific and business expertise in multiple aspects of Quality Management Systems: internal and external cGMP auditing and inspections, training, development of global standards and SOPs, change control, deviations, CAPA management, product complaints, investigations, risk management, testing monographs, pharmacopeia, remediation planning, QC testing, transfers, launches, QC lab. support services. • Extensive expertise in current GxP, ICH, HAs requirements, compendia, data mining, evaluation, trending. Advanced experience in support of the health authorities submissions and questions. Vast partnership with Regulatory Affaires CMC, knowledge of regulatory requirements, strategies and the global product dossiers (CTD module 3).• Successful record in participation/supporting in audits and FDA inspections (front and back offices).• Manage multidisciplinary team of QC/QA professionals with responsibilities in Planning/metrics, Lab. IT support, Equipment/facilities qualification/maintenance, Reference standard management, Data review, AS&T, Testing Monographs, Change Control, Pharmacopoeia.• Proven global leadership skills in managing multiple projects and cross-functional, multidisciplinary teams while maintaining highest level of quality. Comprehensive executive and hands-on experience in aspects of TechOps operations.• Successfully influence in the matrix organization. Exhibit strong communication skills and effective interactions with all levels from associates to senior management.• Lead Global Change Control Operational Excellence team, improving process compliance and delivering efficiencies globally. SME/Super User in Agile PLM, Trackwise, EDMS, etc.• Lead multidisciplinary decommissioning team for the QC laboratory global transfers; manage Change Control and Testing Monographs aspects of the transfers